Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9614747

FEI Number

3001738911

Entity Name

KOBAYASHI SHOJI K.K.

City/State/Country

Kitasaiwai, Nishi-Ku, Yokohama Kanagawa, JP

Establishment Address

NMF Yokohama Nishiguchi Bldg., No. 11-11, 1-Chome, Kitasaiwai, Nishi-Ku, Yokohama Kanagawa 220-0004, JP

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

KOBAYASHI SHOJI K.K. (Owner Number: 9038953)

Owner / Operator Contact Address

NMF Yokohama Nishiguchi Bldg., No. 11-11, 1-Chome, Kitasaiwai, Nishi-Ku, Yokohama, JP-14 220-0004, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K961100

PMA Number

N/A

All Registered Proprietary Names

MYCO Medical phoenix MYCO Medical

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-03-25
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2008-01-20
MSH	Respirator, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-03-25
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2020-01-27
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2020-01-27

Official Correspondent

No official correspondent registered.

US Agent Details

SANJIV KUMAR Business: MYCO MEDICAL SUPPLIES, INC. Email: QA@mycomedical.com Phone: (919) 4602535

Related Public Records

Same Entity

KOBAYASHI SHOJI K.K.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K201622	Guangdong Kingfa Sci. & Tech.Co., Ltd.	Medical surgical mask	2020-11-24
K881618	3M Company	ASEPTEX 1809 FLUID-RESISTANT MOLDED SURGICAL MASK	1988-05-09
K102092	Prestige Ameritech	PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES	2010-10-06

Similar Registrations

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3018382937	MID-AMERICA SAFETY CORP	Elk Grove Village, IL, US
3017598017	DURIO PPE SDN. BHD.	Johor Bahru, MY
3002813051	IRIS USA INC	Pleasant Prairie, WI, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9614747. Last updated year: 2026. Please use registration number 9614747 when referencing this establishment in official correspondence.